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The Nasal/Epistaxis Pack is a sterile, single use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing. The Nasal/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: Separate tissue or structures compromised by surgical trauma; Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; Help control minimal bleeding following surgery or trauma; Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; Act as an adjunct to aid in the natural healing process. The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.

The Nasal/Epistaxis Pack is a sterile, single use, co-polymer of polyethylene glycol (PEG) and chitosan provided as a dry 4.0 cm x 2.4 cm x 0.3 cm pack. Upon placement, the Nasal/Epistaxis Pack absorbs fluids in the field and swells and conforms to the mucosal tissue/treatment site surfaces to separate tissues and prevent adhesions, control minimal bleeding following surgery or trauma, to treat epistaxis, and to act as an adjunct to aid in the natural healing process.

The provided document is a 510(k) summary for the Nasal/Epistaxis Pack, a medical device. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a clinical study with specific acceptance criteria that an AI/device performance would need to meet.

Therefore, the information requested in your prompt (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, training set size) is not applicable to this type of regulatory submission or the device it describes.

A 510(k) submission primarily focuses on comparing the new device's characteristics and performance to existing predicate devices. The "safety and effectiveness information" section in this document refers to comparative performance data demonstrating adequate device performance by showing substantial equivalence, not results from a study designed to meet specific performance metrics against a defined standard or ground truth as would be found in an AI/algorithm-focused study.

Here's an overview of what the document does provide, and why your specific questions are not directly answerable from this text:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures for an AI/diagnostic device. The "acceptance criteria" for a 510(k) submission are typically demonstrating substantial equivalence to a predicate device across various characteristics (e.g., indications for use, design, materials, method of action, sterility, biocompatibility).
• Reported Device Performance: The document states, "In addition, comparative performance test data demonstrated adequate device performance," and "The review of the indications for use and technical characteristics provided demonstrates that the Nasal/Epistaxis Pack is substantially equivalent to the predicate devices." This is a qualitative statement of meeting the equivalence criteria rather than specific numerical performance against a pre-defined metric. The table provided is a comparison of characteristics between the new device and predicate devices.

2. Sample sized used for the test set and the data provenance:

• Not Applicable. This device is a physical sterile pack, not an AI or diagnostic tool that uses a "test set" of data in the typical sense. The "comparative performance test data" mentioned likely refers to bench testing (e.g., absorption capacity, degradation rates) or biocompatibility tests, not a clinical trial with a "test set" for performance evaluation against a diagnostic ground truth.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. Ground truth, in the context of AI/diagnostic device evaluation, refers to the definitive determination of a condition (e.g., confirmed disease or pathology) used to assess the device's accuracy. This concept does not apply to a physical medical device like the Nasal/Epistaxis Pack.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. An MRMC study is designed for evaluating diagnostic devices, especially those involving human interpretation, and often the impact of AI assistance. This device is not a diagnostic tool or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. See point 3.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device that requires a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

Summary of what is provided in the K113585 document:

• Device Name: Nasal/Epistaxis Pack
• Product Description: Sterile, single-use co-polymer of polyethylene glycol (PEG) and chitosan, provided as a dry 4.0 cm x 2.4 cm x 0.3 cm pack. It absorbs fluids, swells, conforms to tissue, separates tissues to prevent adhesions, controls minimal bleeding, and aids in healing.
• Indications for Use:
  • As a space-occupying packing in nasal/sinus surgery to:
    • Separate tissue/structures compromised by surgical trauma.
    • Separate and prevent adhesions between mucosal surfaces.
    • Help control minimal bleeding following surgery or trauma (by tamponade effect, blood absorption, platelet aggregation).
    • Act as an adjunct to aid in the natural healing process.
  • As a nasal packing to treat epistaxis.
• Predicate Devices:
  • Nasopore® manufactured by Polyganics BV (K052099)
  • Sepragel ENT Bioresorbable Packing/Stent manufactured by Genzyme Corporation (K043035)
  • Rhinocell® Nasal Packings manufactured by Boston Medical Products, Inc. (K972459)
  • MeroPack Bioresorbable Nasal Packing and Sinus Stent manufactured by Medtronic Xomed Inc. (K041381)
  • MeroGel™ Control Gel ENT Surgical Dressing manufactured by Medtronic Xomed Inc. (K002972)
• Basis for Substantial Equivalence: The Nasal/Epistaxis Pack shares the same indications for use, device operation, overall technical and functional capabilities with the predicate devices. Comparative performance test data demonstrated adequate device performance in supporting this claim of substantial equivalence. The provided table details the comparison of characteristics, including product codes, regulations, ingredients, method of action/removal, sterility, biocompatibility, and how supplied, across the new device and its predicates.

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